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Completed

NCT Number: NCT03217942

Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model

The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

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Key information

Conditions

Hyperalgesia Healthy Subjects Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Aalborg University

Aalborg, 9220, Denmark

About this study

Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy and pain free volunteers

Exclusion criteria

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, mental illnesses, or psychiatric diseases.
  • Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
  • Participation in other pain trials throughout the study period
  • Lack of ability to cooperate
  • Taking any analgesic 24 hours before the injections
  • Performing any strenuous leg exercise through out the study period causing sore muscles

Treatment and study plan

NGF

Drug

Intramuscular injection

Other names: Beta-Nerve Growth Factor, Human

Primary outcomes

  1. Muscle sensitivity

    Time frame: Change from baseline at 3 weeks

    Pressure pain thresholds (PPTs) are assessed over the tibialis anterior muscles using a handhold pressure algometer.

Secondary outcomes

  1. Pressure-induced referred pain

    Time frame: Change from baseline at 3 weeks

    At three predetermined sites within the tibialis anterior muscle, a constant pressure stimulation (120% of PPT) is evoked by use of the pressure algometer. Subjects color their perceived sensation of pain on an electronic schematic of the lower legs using Navigate Pain.

  2. Activity-induced muscle soreness

    Time frame: Change from baseline at 3 weeks

    Subjects perform 10 dorsiflexions with each leg. The perceived muscle soreness is reported using a numeric rating scale (NRS) and the area of soreness is colored on an electronic schematic of the lower legs (Navigate Pain).

  3. Pain intensity

    Time frame: Assessed continuously at 0-5 min during the injections at each leg

    Subjects rate their perceived pain intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.

  4. Muscle soreness Diary

    Time frame: Change from baseline at 3 weeks

    Two times a day subjects evaluate their muscle soreness using a Likert Scale of muscle soreness for lower limp

  5. Activity-induced muscle soreness Diary

    Time frame: Change from baseline at 1 week

    Subjects perform 10 dorsiflexions with each leg. The perceived muscle soreness is reported using a numeric rating scale (NRS) and the area of soreness is colored on an electronic schematic of the lower legs (Navigate Pain). The activity is performed at home on days in between the sessions

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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